EmbracePlus

by Empatica S.R.L.  · Based in Italy →Pioneer in digital biomarker development and continuous health monitoring driven by AI.
Cardiology Neurology Pulmonology

Regulatory Status Disclosed

Overview

Empatica’s EmbracePlus is a medical-grade wearable device at the core of the Empatica Health Monitoring Platform, designed for continuous physiological monitoring in clinical research and healthcare. It collects a broad range of high-quality raw physiological data, including pulse rate, pulse rate variability, respiratory rate, blood oxygen saturation (SpO2), electrodermal activity (EDA), skin temperature, and actigraphy data, via advanced sensors (PPG, EDA, accelerometer, gyroscope, digital temperature). The platform provides access to both raw data and clinically validated digital biomarkers, enabling researchers and healthcare professionals to gain insights into various health conditions. Data is seamlessly transferred via Bluetooth to a dedicated mobile app (Empatica Care App or Care Lab App) and then securely uploaded to the Empatica Cloud for review, analysis, and management through portals like the Care Portal or Research Portal. The platform also offers a Cloud API for integration with existing clinical trial management systems (CTMS) and electronic data capture (EDC) platforms, streamlining data flow and enhancing trial efficiency. EmbracePlus is designed for comfort and ease of use, featuring a water-resistant design and on-wrist charging capabilities to ensure high patient compliance and uninterrupted data collection.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Continuous physiological monitoring (PR, HRV, RR, SpO2, Temp, EDA, Actigraphy)
  • Medical-grade sensors (PPG, EDA, Accelerometer, Gyroscope, Digital Temperature)
  • Access to raw data (Avro format) and CSV export
  • Clinically validated and research-grade digital biomarkers
  • Cloud-based data storage and management (Empatica Cloud, Care/Research Portals)
  • Dedicated mobile apps (Empatica Care, Care Lab, EpiMonitor)
  • Cloud API for integration with CTMS/EDC systems
  • Water-resistant (IP67) and comfortable design
  • Long battery life (up to 28 days for platform, 14 days with Cloud API, >24 hours for wristband)
  • On-wrist charging with patent-pending sleek pod

Use Cases

  • Decentralized and hybrid clinical trials
  • Academic research studies
  • Remote patient monitoring
  • Parkinson's and movement disorders monitoring
  • Epilepsy seizure detection and alerts (with EpiMonitor)
  • Sleep and activity tracking

What Physicians Need to Know

Clinical Trial Data Collection & Management
EmbracePlus is an FDA-cleared medical wearable designed for remote, continuous, and unobtrusive collection of high-precision physiological data from participants in clinical trials. The Empatica Health Monitoring Platform facilitates study management, participant monitoring, and compliance tracking across multiple sites.
Real-World Evidence Analysis
The device collects raw data and over 300 clinically validated and research-grade digital biomarkers (e.g., pulse rate, respiratory rate, skin conductance, SpO2, actigraphy, temperature) in real-world settings. This data is crucial for generating real-world evidence, understanding treatment effectiveness, patient behavior, and long-term outcomes in diverse populations.
Safety Signal Detection
Continuous monitoring of physiological parameters such as electrodermal activity (EDA), photoplethysmogram (PPG), skin temperature, accelerometer data, and SpO2 enables researchers to visualize digital biomarkers and patient data within the Care Portal, aiding in the early detection of patterns and potential adverse events.
Collaboration Features
The Empatica Health Monitoring Platform, accessible via the Care Portal/Research Portal, supports collaboration among research teams, CRO personnel, and study coordinators by providing tools to manage studies, access data, and monitor compliance across various sites.
Publication Support
Empatica's technology has been utilized in thousands of published scientific papers. The platform provides access to high-quality raw data and an extensive range of digital biomarkers, directly supporting researchers in generating robust scientific evidence for publications.
Physician Tip

EmbracePlus offers physicians a powerful tool for remote, continuous monitoring of patient physiology in real-world settings. This provides objective data on vital signs, activity, and autonomic responses, which can enhance understanding of disease progression, treatment efficacy, and potential adverse events outside of clinical visits. The ability to access high-quality digital biomarkers can support personalized care and inform clinical decision-making, especially for conditions requiring longitudinal monitoring.

The Empatica Health Monitoring Platform, powered by EmbracePlus, offers robust Cloud APIs for seamless integration with existing clinical trial management systems (CTMS) and other research platforms. This allows for automated data transfer, centralized participant management using existing IDs, and streamlined workflows, reducing study complexities and enhancing data accessibility for researchers and sponsors.

Details

Category Drug Discovery & Research, Wearables & Remote Monitoring (RPM)
Pricing Quote-based for research and clinical trials; subscription plans for specific clinical applications like epimonitor.
  • Quote-based for research and clinical trials; subscription tiers (Basic, Standard, Plus) for EpiMonitor, with monthly and annual options and discounts for annual plans
DeploymentCloud-based, with data collected via wearable device and companion mobile application.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Empatica Health Monitoring Platform, which includes EmbracePlus, received FDA clearance (K221282, K230457, K242737) for continuous data collection to monitor Electrodermal Activity (EDA), SpO2, skin temperature, movement during sleep, pulse rate, and respiratory rate.

Integrations
EHR Not specified
Specialties Cardiology, Neurology, Pulmonology

What the Web Says

The Empatica EmbracePlus is a medical-grade wearable designed for continuous health monitoring, particularly focused on epilepsy and stress management. It tracks physiological indicators like heart rate, temperature, and electrodermal activity to provide insights into stress patterns and detect seizures. The device is praised for its advanced monitoring capabilities, user-friendly design, and the ability to provide raw, accessible data for research and clinical use.

Overall: Positive

Strengths

  • Advanced monitoring of physiological indicators (heart rate, temperature, electrodermal activity).
  • Provides valuable insights into stress patterns and helps identify triggers.
  • FDA-cleared for seizure detection in adults and children aged six and above, with a 98% accuracy rate and minimal false alarms.
  • Comfortable, user-friendly, and designed for everyday wear with a long battery life (up to one week).
  • Offers access to high-quality raw data and an extensive range of digital biomarkers for research.
  • Caregivers receive alerts via phone calls and SMS with the user's location for prompt assistance during seizures.

Limitations

  • Some users report false alarms for seizure detection.
  • Data loss due to low-quality signals, often attributed to movement or poor device fitting.
  • Raw data can be difficult to access and manage without purpose-built software, and there's no clear standard for data processing across studies.
  • Lack of a comprehensive caregiver view or shared app login for monitoring data and trends.
  • Limited display functionality (only shows time and battery life).
  • Some features, like SOS alerts, are behind a higher subscription tier.

Based on reviews from: Super Health Lab, Empatica, Medigy, Reddit, PMC, G2, Capterra

Last updated: 2026-07-21

Ratings & Reviews

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Press & Coverage

PRNewswire
Empatica Announces EmbracePlus: NASA Medical Quality in a Down-to-Earth Smart Watch
Empatica announced EmbracePlus, a new smartwatch developed in partnership with TRISH (Translational Research Institute for Space Health) for NASA, designed for health monitoring during deep space missions and set to ship to clients in summer 2020. The device is built for high-quality, long-term medical sensing in challenging environments and can run custom AI algorithms.
2019-11
Empatica
The EmbracePlus wearable wins European CE mark - Empatica
Empatica's EmbracePlus wearable received the European CE mark as a Class IIa medical device, recognizing its ability to consistently provide quality physiological parameters. This certification enhances its use for remote and passive data collection in clinical trials and continues its partnership with TRISH for astronaut health monitoring.
2021-04
Empatica
Empatica receives landmark FDA PCCP authorization for pulse oximetry
Empatica achieved a landmark FDA Predetermined Change Control Plan (PCCP) authorization for its pulse oximetry (SpO2) algorithm, making it the first such authorization for a pulse oximetry device. This allows for faster deployment of algorithm refinements without new 510(k) applications, benefiting clinical trials using the Empatica Health Monitoring Platform and EmbracePlus.
2025-06
Business Wire
Empatica's Medical-Grade EmbracePlus Wearable Selected for Critical US Department of Defense PTSD Treatment Study - Business Wire
Empatica's EmbracePlus has been chosen by the US Department of Defense for a clinical study on PTSD treatment, utilizing its sensors to track physiological data like sleep, actigraphy, and electrodermal activity. Researchers aim to use this data to diagnose and predict PTSD subtypes and monitor treatment effects, potentially leading to personalized care.
2024-02
Empatica
Empatica's AI-powered seizure watch now CE certified, launches across Europe
Empatica's EpiMonitor, leveraging the EmbracePlus watch and a companion mobile app, has received CE MDR certification and is now available in Europe for epilepsy monitoring. The medical-grade solution uses AI-based algorithms with 98% accuracy to detect tonic-clonic seizures and alert caregivers, also providing an automated diary for sleep, activity, and seizure tracking.
2025-05
Empatica
The Empatica Health Monitoring Platform receives FDA-clearance
Empatica's Health Monitoring Platform, built on data from the EmbracePlus wearable, received FDA clearance as a full-stack remote health monitoring and data collection solution for research and healthcare professionals. The platform includes Empatica's Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers for monitoring Electrodermal Activity, SpO2, and more.
2022-11
Empatica
Empatica Receives European MDR Certification for Health Monitoring Platform
Empatica's Health Monitoring Platform, which includes the EmbracePlus wearable, has received CE Mark Certification under the European Union's Medical Device Regulation (MDR). This certification, alongside its existing FDA clearance, establishes it as a comprehensive wearable and digital biomarker solution for global clinical trials.
2024-12
Tech Briefs
Medical-Grade Smartwatch Can Monitor Astronauts, Patients - Tech Briefs
The EmbracePlus, developed with NASA-backed funding, is a medical-grade smartwatch capable of monitoring astronauts in space, as well as outpatients and clinical trial participants. It integrates five sensors for comprehensive data collection, including an accelerometer, temperature sensor, infrared sensor for cardiac and respiratory activity, and a sensor for electrical activity in the skin.
2024-06

Videos

Product demos, reviews, and walkthroughs for EmbracePlus.

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Frequently Asked Questions

EmbracePlus utilizes embedded AI/ML algorithms to continuously process raw physiological data from its sensors, extracting specific parameters like pulse rate, respiratory rate, blood oxygen saturation (SpO2), temperature, and electrodermal activity. These AI-powered capabilities enable the development and monitoring of digital biomarkers, supporting remote patient monitoring and providing insights for clinical research and trials.
EmbracePlus is FDA-cleared as part of the Empatica Health Monitoring Platform (K221282 - K230457) and is CE-certified as a Class IIa medical device. The Empatica Health Monitoring Platform, which EmbracePlus is a part of, is also GDPR and HIPAA compliant, ensuring robust data security and privacy for sensitive health information.
EmbracePlus is not intended as a primary diagnostic tool and should not be used as the sole basis for clinical decision-making. It is also not designed for use in high-acuity environments, such as an ICU or operating room, nor for acutely ill cardiac patients with potential life-threatening arrhythmias. Additionally, some research indicates limitations in capturing certain electrodermal activity (EDA) signals compared to reference devices.
Yes, several other medical-grade wearables and platforms offer physiological monitoring. Alternatives for actigraphy and sleep-wake monitoring include ActiGraph LEAP, Ambulatory Monitoring Micro Motionlogger/SleepWatch 2.0, and SOMNOmedics SOMNOwatch Plus/eco. Other notable medical wearables mentioned for health monitoring include the Apple Watch Series 9, Fitbit Sense 2, Garmin Venu 2 Plus, and the Oura Ring Gen 3, some of which also incorporate AI for health insights.
Pricing for EmbracePlus varies depending on the use case, such as for academic research or specific clinical solutions like EpiMonitor. For research, the Empatica Health Monitoring Platform offers bundles including the device and multi-year data access, with academic discounts available. For epilepsy monitoring, EpiMonitor, which uses EmbracePlus, has a one-time device fee and monthly subscription plans. Healthcare providers interested in integrating EmbracePlus into their clinical practice are advised to contact Empatica's sales team directly for tailored pricing and solutions.
EmbracePlus provides access to raw data and utilizes FDA-cleared digital biomarkers for various physiological parameters, indicating a level of clinical validation. For instance, its SpO2 algorithm has demonstrated clinically acceptable accuracy in controlled hypoxia studies. While the device offers valuable insights for monitoring, physicians should interpret the AI-generated data as supplementary information, as it is not intended for primary diagnosis.
Yes, the Empatica Health Monitoring Platform offers a Cloud API designed for seamless integration with existing clinical trial management systems (CTMS) and Electronic Data Capture (EDC) platforms. This allows for direct integration of patient health data, both raw and as digital biomarkers, into a healthcare provider's infrastructure and EHR from the Empatica cloud.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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